Salsalate as an Adjunctive Treatment for Patients With Schizophrenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Massachusetts, Worcester
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Xiaoduo Fan, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01578486
First received: April 11, 2012
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

This is a 12-week, open-label trial of salsalate 3 g/day as an adjunctive treatment in 15 schizophrenia subjects to examine salsalate's effect on psychopathology, cognitive functioning, and metabolic parameters.

Potential subjects will be identified by their clinicians at the Freedom Trail Clinic, or Massachusetts General Hospital. A total of 15 subjects will be enrolled.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: salsalate
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Salsalate as an Adjunctive Treatment for Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • PANSS Total Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Positive and negative symptoms of schizophrenia will be measured by total score on Positive and Negative Syndrome Scale (PANSS).

  • SANS Total Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Negative symptoms of schizophrenia will be measure by total score on the Scale for Assessment of Negative Symptoms (SANS)

  • MATRICS Total Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Improved cognition will be measured using the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) assessment


Secondary Outcome Measures:
  • HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Hemoglobin A1c (HbA1c) will be used to measure glucose levels. HbA1c will be measured as a percentage.

  • Fasting Glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Fasting Blood Sugar levels will be measured

  • Fasting Insulin [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Fasting insulin levels will be measured by uUnits/ml.

  • Lipid Profile [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Total cholesterol, HDL cholesterol, LDL cholesterol, and triglyceride levels will be measured.

  • hs-CRP [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    High-sensitivity C-reactive protein (hs-CRP) will be measured in mg/L in order to detect inflammation. Higher hs-CRP values correspond to higher levels of inflammation.

  • TNF-alpha [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Tumor necrosis-alpha factor will be measured to assess inflammation levels.

  • IL-6 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Interleukin-6 levels will be measured to detect inflammation


Estimated Enrollment: 15
Study Start Date: December 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: salsalate
open-label trial of salsalate 3g/day
Drug: salsalate
open-label trial of salsalate 3g/day for 12 weeks.

Detailed Description:

The specific aims include:

Primary aims:

  1. Examine the efficacy of salsalate (3g/day) in improving positive and negative symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) and the Scale for Assessment of Negative Symptoms (SANS).
  2. Examine the efficacy of salsalate in improving cognition as measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) composite score.

Secondary aims:

  1. Examine salsalate's effects on Hemoglobin A1c (HbA1c), fasting glucose, insulin and lipids.
  2. Examine salsalate's effects on high sensitivity C-reactive protein (hs-CRP), TNF-α and IL-6.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65 years;
  • Diagnosis of schizophrenia or schizoaffective disorder;
  • Stable dose of the current antipsychotic drug for at least one month;
  • Well established compliance with outpatient treatment per treating clinician's judgment;
  • Able to complete the cognitive assessment battery (must be English speaking);
  • Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods during the study.

Exclusion Criteria:

  • Inability to provide informed consent;
  • Current substance abuse;
  • Psychiatrically unstable per treating clinician's judgment;
  • Significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases;
  • Currently on immunosuppressant medication including oral steroids;
  • Use of anti-coagulants (heparin, LMWH, warfarin, cilostazol, clopidogrel, dabigatran);
  • History of chronic infection (including, HIV and hepatitis), malignancy, organ transplantation, blood dyscrasia, central nervous system demyelinating disorder, and any other known autoimmune or inflammatory condition;
  • Experienced asthma, urticaria or allergic type reaction after taking aspirin, salsalate, or other NSAIDS;
  • Pregnancy or breastfeeding;
  • Pre-existing chronic tinnitus.
  • Known hypersensitivity to salsalate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01578486

Contacts
Contact: Matthew R Goodnow, BS 508-856-2494 Matthew.Goodnow@umassmed.edu

Locations
United States, Massachusetts
University of Massaschusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01605
Principal Investigator: Xiaoduo Fan, MD         
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Xiaoduo Fan, MD, MPH, MS UMass Medical School
Study Director: Matthew R Goodnow, BS UMass Medical School
  More Information

No publications provided

Responsible Party: Xiaoduo Fan, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01578486     History of Changes
Other Study ID Numbers: 2011-P-000798
Study First Received: April 11, 2012
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
Schizophrenia
Cognition
Metabolism
Antipsychotics
Psychopathology

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Sodium Salicylate
Salicylsalicylic acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014